Minimally invasive surgical assembly and methods

ABSTRACT

A minimally invasive surgical assembly broadly includes an outer hollow needle which has an outer diameter of 3.0 mm or smaller, and a coaxial surgical instrument having a shaft which extends through the outer hollow needle. The coaxial surgical instrument includes end effectors at the end of the shaft which are biased to an open position such that when the end effectors of the surgical instrument extended out of the needle they open, and they are closed by relative movement of the needle over them. The assembly preferably includes a first fixing element which is used to fix the relative location of the surgical instrument and the needle. The assembly also preferably includes a second fixing element which moves relative to the needle and is located on the outside thereof and which is used to fix the relative location of the needle to the patient.

CROSS-REFERENCE TO RELATED APPLICATION

This patent application is a continuation application and claims thepriority benefit of co-pending U.S. patent application Ser. No.11/685,522 filed Mar. 13, 2007, which claims priority to U.S.Provisional Patent Application No. 60/781,556 filed Mar. 13, 2006, toU.S. Provisional Patent Application No. 60/828,916 filed Oct. 10, 2006,and to U.S. patent application Ser. No. 11/420,927 filed May 30, 2006,all of which are hereby incorporated by reference herein in theirentireties by this reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates broadly to surgical instruments and methods oftheir use. More particularly, this invention relates minimally invasivesurgical instruments incorporating a needle and a working device whichextends through and beyond the needle and which can be retracted intothe needle. The invention has particular application tolaparoscopic-type surgery, although it is not limited thereto.

2. State of the Art

Over the last two decades, minimally invasive surgery has become thestandard for many types of surgeries which were previously accomplishedthrough open surgery. Minimally invasive surgery generally involvesintroducing an optical element (e.g., laparoscope or endoscope) througha surgical or natural port in the body, advancing one or more surgicalinstruments through additional ports or through the endoscope,conducting the surgery with the surgical instruments, and withdrawingthe instruments and scope from the body. In laparoscopic surgery(broadly defined herein to be any surgery where a port is made via asurgical incision, including but not limited to abdominal laparoscopy,arthroscopy, spinal laparoscopy, etc.), a port for a scope is typicallymade using a surgical trocar assembly. The trocar assembly oftenincludes a port, a sharp pointed element (trocar) extending through andbeyond the distal end of the port, and at least in the case of abdominallaparoscopy, a valve on the proximal portion of the port. Typically, asmall incision is made in the skin at a desired location in the patient.The trocar assembly, with the trocar extending out of the port is thenforced through the incision, thereby widening the incision andpermitting the port to extend through the incision, past any facie, andinto the body (cavity). The trocar is then withdrawn, leaving the portin place. In certain circumstances, an insufflation element may beattached to the trocar port in order to insufflate the surgical site. Anoptical element may then be introduced through the trocar port.Additional ports are then typically made so that additional laparoscopicinstruments may be introduced into the body.

Trocar assemblies are manufactured in different sizes. Typical trocarport sizes include 5 mm, 10 mm and 12 mm (available from companies suchas Taut and U.S. Surgical), which are sized to permit variously sizedlaparoscopic instruments to be introduced therethrough including, e.g.,graspers, dissectors, staplers, scissors, suction/irrigators, clamps,forceps, biopsy forceps, etc. While 5 mm trocar ports are relativelysmall, in some circumstances where internal working space is limited(e.g., children), it is difficult to place multiple 5 mm ports in thelimited area. In addition, 5 mm trocar ports tend to limit movements ofinstruments inside the abdominal cavity to a great extent.

Further, while laparoscopic surgery has reduced the trauma associatedwith various surgical procedures and has concomitantly reduced recoverytime from these surgeries, there always remains a desire in the art tofurther reduce the trauma to the patient.

One area of trauma associated with laparoscopic surgery identified bythe inventor hereof as being susceptible of reduction are the scarswhich result from the trocar ports used. In many laparoscopic surgeries,three or more trocar incisions are made. For example, in laparoscopichernia repair surgery, four trocar incisions are typically made, withone incision for insufflating the abdomen and inserting the opticaldevice, two incisions for trocar ports for inserting grasperstherethrough, and a fourth port for passing a stapler therethrough.Those skilled in the art and those who have undergone surgicalprocedures recognize that even the 5 mm trocar ports leave holes whichmust be stitched and which result in scars.

A second area of trauma associated with laparoscopic surgery identifiedby the inventor hereof as being susceptible of reduction relates totrauma resulting from the manipulation (angling) of the trocar portsrequired in order to conduct the surgery due to inexact placement.Angling of the port can cause tearing at the incision periphery.

Those skilled in the art will also appreciate that because of the numberof trocar assemblies and laparoscopic tools used in laparoscopic surgery(most of which are disposable because of the cost and complicationsassociated with autoclaving), the cost of laparoscopic surgery is high.Thus, there always remains a desire in the art to provide lower costlaparoscopic tools.

SUMMARY

It is therefore an object of the invention to provide a minimallyinvasive surgical assembly which reduces trauma to the patient relativeto presently used systems.

It is another object of the invention to provide a minimally invasivesurgical assembly which is simple and inexpensive relative to presentlyused systems.

It is a further object of the invention to provide a minimally invasivesurgical assembly which utilizes a 3 mm or smaller incision/port device.

It is also an object of the invention to provide a minimally invasivesurgical assembly which will not scar a patient.

It is an additional object of the invention to provide a minimallyinvasive surgical assembly utilizing effective surgical instrumentswhich are inserted into a 3 mm or smaller port device.

It is still another object of the invention to provide a minimallyinvasive surgical assembly with reduced number of parts.

In accord with these objects, which will be discussed in detail below, aminimally invasive surgical assembly according to the invention broadlyincludes an outer hollow needle which has an outer diameter ofsubstantially 2.5 mm (the term “substantially”, for purposes of thisapplication meaning .+−.20%), and preferably a diameter of 2.5 mm orsmaller and a coaxial surgical instrument having a shaft which extendsthrough the outer hollow needle. The coaxial surgical instrumentincludes end effectors at the end of the shaft which are biased to anopen position such that when the end effectors of the surgicalinstrument extend out of the needle they open, and they are closed byrelative movement of the needle over them. The assembly preferablyincludes a first fixing element which is used to fix the relativelocation of the surgical instrument and the needle. The assembly alsopreferably includes a second fixing element which moves relative to theneedle and is located on the outside thereof and which is used to fixthe relative location of the needle to the patient. The second fixingassembly may include an anchoring element which permits the needle to beheld at different angles relative to the patent

According to an embodiment of the invention, the surgical instrument andneedle are sized to a very small controlled clearance therebetween sothat at least a portion of the shaft of the surgical instrument slidesagainst the inner surface of the needle, thereby forming a seal which iseffective against desufflation.

According to another embodiment of the invention, the surgical assemblyincludes a safety mechanism which prevents inadvertent withdrawal of theend effectors of the surgical instrument totally within the needle suchthat the needle tip will be “exposed” (i.e., will not have the endeffectors extending slightly outward therefrom). The safety mechanismpreferably includes an override means so that the assembly can beinitially placed in an “armed” position with the needle tip exposed forpurposes of initial puncture, as well as for purposes of re-arming.

The surgical assembly of the invention may be used during laparoscopicsurgery instead of using an extra trocar and laparoscopic instrument. Inparticular, with the surgical instrument (e.g., grasper) partiallyinserted in the needle (i.e., with the end effectors at least partiallywithdrawn inside the needle) and optionally locked relative to eachother by the first fixing element, the needle is used to puncture theskin and advance into the body (e.g., the abdomen). At a desiredlocation (typically under guidance of an already inserted scope), themovement of the needle is stopped. The surgical instrument is thenunlocked (if previously locked) and advanced until the end effectorsextend past the needle and open to their neutral stress position. Theneedle and surgical instrument may then further advanced until the endeffectors extend over a structure in the body. Then, with the surgicalinstrument stationary, the needle is advanced relative to the surgicalinstrument to force the end effectors closed, thereby securely graspingthe structure. The first fixing element may then be used to fix theneedle relative to the surgical instrument to prevent release of thegrasped structure. If desired, the needle with the surgical instrumentfixed relative thereto and grasping the structure may be manipulatedrelative to the body wall (e.g., to lift, push, or otherwise move thestructure). When the needle (or the grasped structure) is in a desiredlocation in the body, the second fixing element is slid along the needleand into engagement with the skin of the patient, thereby fixing thegrasping end effectors at a desired location in the body. At any time,the grasped structure can be released by causing the first fixingelement to release the surgical instrument and then moving the needlebackward (proximally) relative to the surgical instrument, therebypermitting the end effectors to reopen. The surgical assembly can bepulled out of the body (preferably with the surgical instrument firstmoved backward relative to the needle to retract and close the endeffectors and locate them inside the needle) leaving just a smallpuncture mark which will often heal without a scar.

The surgical assembly of the invention thereby accomplishes the objectsof the invention with a minimum number of parts and may be used toreplace expensive trocar assemblies and laparoscopic instruments.

Additional objects and advantages of the invention will become apparentto those skilled in the art upon reference to the detailed descriptiontaken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an enlarged broken cross sectional view of a first embodimentof the surgical assembly of the invention with the end effectors of thesurgical instrument in an open (advanced) position.

FIG. 2 is an enlarged broken cross sectional view of a first embodimentof the surgical assembly of the invention with the end effectors of thesurgical instrument in a closed (retracted) position.

FIGS. 3A-3E are broken representations of five different fixing elementsystems for fixing the shaft of surgical instrument relative to theneedle.

FIG. 4 is a representation of a first embodiment of an anchoring elementfor fixing the location of the surgical assembly relative to thepatient.

FIGS. 5A and 5B are respective top and side views of another embodimentof an anchoring element for fixing the location of the surgical assemblyrelative to the patient.

FIG. 6 is a schematic view of another mechanism fixing the location ofthe surgical assembly relative to the patient.

FIGS. 7A-7G are representations of seven different end effectors for thesurgical instrument of the invention.

FIG. 8A-8D are representations of a modified surgical instrument havingend effectors acting as an obturator, and with the end effectors locatedin a rest shielding position, a puncturing position, an extendedposition, and a withdrawn position respectively.

FIGS. 9A-9D are schematic diagrams showing the use of four surgicalassemblies of the invention being used for a hernia repair operation.

FIG. 10 is a front view of a thumb hold of a surgical instrument.

FIGS. 11A-11C are three views of a plunger which couples the thumb holdand shaft of a surgical instrument.

FIGS. 12A-12B are perspective views of the inside and outside of onehalf of a proximal housing.

FIGS. 13A-13B are perspective views of the inside and outside of asecond half of the proximal housing.

FIG. 14 is a perspective view of a lock mechanism for the surgicalinstrument.

FIG. 15A-15B are perspective views of a needle hub and needle tip.

FIGS. 16A-16E are transparent views of the safety/locking mechanism withthe plunger in a fully retracted position, a beginning deploymentposition, a position just prior to reaching a safety locking position,the safety locked position, and a working or operating range positionrespectively.

FIG. 17 is a view of the distal end of the surgical assembly with theend effectors assuming a safety position relative to the needle tip.

FIGS. 18A-18B are partially transparent side and perspective viewsshowing the lock mechanism engaging the plunger in an unlocked position.

FIGS. 19A-19B are perspective and side views of the proximal portion ofthe assembly showing the lock mechanism engaging the plunger in a lockedposition.

FIG. 20A is a perspective view of the complete assembly extendingthrough a second fixing element.

FIG. 20B is a perspective view of a proximal portion of the assemblywith only part of a housing shown.

FIGS. 21A-21D are an exploded view, an assembled view, a top view, and across-sectional view of a third embodiment of the second fixing means ofthe invention.

FIG. 21E is a bottom view of the body of FIGS. 21A-21D.

FIG. 21F is a perspective view of the squeezable ball of FIGS. 21A-21D.

FIG. 21G is a perspective view of the base of FIGS. 21A-21D.

DETAILED DESCRIPTION

A minimally invasive surgical assembly 10 according to the invention andas seen in FIGS. 1 and 2 broadly includes an outer hollow needle 12which has an outer diameter of substantially 2.5 mm (0.1 inches), and acoaxial surgical instrument 14 having a shaft 15 which extends throughthe outer hollow needle. The needle 12 has a sharpened distal end 18which is angled at about 35.degree. relative to a longitudinal axis ofthe needle, and a proximal end having a knob or handle 20 for holdingand manipulation of the needle. The inside diameter of the needle issubstantially 2.0 mm (0.08 inches) and the wall thickness of the needleis substantially 0.25 mm (0.01 inch). The needle is typically between 10and 30 cm long, and more typically between 13 and 18 cm long (althoughother sizes could be used, depending upon the surgery involved, andtypically larger for obese patients and smaller for infants and smallchildren), and is preferably made from stainless steel, although othermaterials could be utilized.

The coaxial surgical instrument 14 shown in FIGS. 1 and 2 is a graspertype instrument and includes end effectors 22 at the distal end of theshaft 15 and a handle or knob 24 at the proximal end of the shaft. Theend effectors 22 are formed so that they biased to an open position asseen in FIG. 1, such that when the end effectors 22 of the surgicalinstrument 14 extend out of the needle 12 they open, and when the needleextends over them as in FIG. 2, they close. The end effectors 22 may beformed from the end of the shaft 15 as described in U.S. Pat. No.6,616,683 to Toth et al. which is hereby incorporated by referenceherein in its entirety, or in any other desired manner such as byforming end effectors and connecting them to the shaft. The shaft 15 ofthe surgical instrument 14 must be long enough to permit the endeffectors to extend out of the needle as seen in FIG. 1. The surgicalinstrument 14 is preferably made from stainless steel, although othermaterials could be utilized for all or part of the instrument 14.

More particularly, in one embodiment, where the surgical instrument isto be used for grasping, (i.e., the end effectors are graspers as shown,e.g., in FIGS. 1, 7A-7F, 8A-8D and 17), the graspers can be formed fromsixty percent cold reduction Custom 475 precipitation-hardenablemartensitic stainless steel wire available from Carpenter Specialty WireProducts, Orangeburg, S.C. The stainless steel wire is described in U.S.Pat. No. 6,630,103 which is hereby incorporated by reference herein inits entirety and includes 9.0%-13.0% and more preferably 10.5-11.5%chromium, 5.0%-11.0% and more preferably 8.0%-9.0% cobalt, 7.0%-9.0% andmore preferably 7.5%-8.5% nickel, 3.0%-6.0% and more preferably4.75%-5.25% molybdenum, 1.0%-1.5% and more preferably 1.1%-1.3%aluminum, 1.0% and more preferably 0.005-0.05% titanium (maximum), 0.5%and more preferably 0.1% silicon (maximum), 0.75% and more preferably0.25% copper (maximum), 0.5% and more preferably 0.1% manganese(maximum), 0.025% and more preferably 0.0025% sulfur (maximum), 0.03%and more preferably 0.015% carbon (maximum), 1.0% and more preferably0.20% niobium (maximum), 0.04% and more preferably 0.015% phosphorus(maximum), 0.03% and preferably 0.01% nitrogen (maximum), 0.02% andpreferably 0.003% oxygen (maximum), 0.01% and preferably 0.0015-0.0035%boron, and remainder iron. The wire may be subject to an EDM procedureto form the end effectors as approximately 1.8 mm graspers with teeth(e.g., as shown in FIG. 7G—169 a, and FIG. 17—569) or other structures,and then subject to precipitation age hardening heat treatment attypically 975.degree. F. for an hour. The resulting end effectors have ahigh yield strength, typically in excess of 300,000 psi, with goodelongation and toughness. This provides a clinical advantage in thatwhen too much material is placed in the end effectors and the endeffectors are actuated, the jaws will neither crush the material, norfracture themselves, but will plastically deform.

According to one aspect of the preferred embodiment of the invention,the surgical instrument 14 and needle 12 are sized so that at least aportion of the shaft 15 of the surgical instrument 14 slides against theinner surface of the needle 12, thereby forming a seal which iseffective against desufflation. Thus, where the inner diameter of theneedle is 2.00 mm, the outer diameter of the shaft 15 is approximately1.99 mm (0.078 inches), or about 0.01 mm smaller than the inner diameterof the needle. This small difference in diameters results in a slidinglow clearance fit which can be felt as a drag and which effectively actsas a seal against desufflation. If desired, only a portion of the shaftbe sized to interferingly slide against the inner surface of the needle.Alternatively, the needle may include an internal gasket or seal orgrease which seals against the outer diameter of the shaft.

Turning to FIGS. 3A-3E, according to the preferred embodiment, theassembly 10 of the invention includes a first fixing mechanism, element,or system which is used to fix the relative location of the surgicalinstrument 14 and the needle 12. In FIG. 3A, the first fixing system 50is shown to include notches 52 on the shaft 15 of the surgicalinstrument 14, and a screw 54 which extends through a threaded radialhole 55 in the needle 12 or its handle. When it is desired to fix thesurgical instrument 14 relative to the needle 12, the screw 54 isscrewed (typically clockwise) into the needle and into engagement with anotch 52. When it is desired to release the surgical instrument 14, thescrew 54 is unscrewed so that it is no longer engaged in the notch. Itwill be appreciated that instead of a screw 54 and a threaded radialhole 55, a spring loaded pin which extends through a radial hole in theneedle (or needle handle) could be utilized to lock the surgicalinstrument 14 relative to the needle 12.

In FIG. 3B, a second fixing system 50′ is shown to include radialgrooves 60 on the shaft 15 of the surgical instrument and a clip 61having spring arms 62 (one shown), and a shaft 63. The shaft 63 of theclip 61 extends through a wall of the needle or, more preferably, itshandle, and the spring arms 62 engage a radial groove 64 on the shaft15. When the shaft 15 of the needle is pushed or pulled relative to theneedle, the spring arms 62 spread to permit movement of the shaft 15past the clip 61. It will be appreciated that if the spring arms 62 aresufficiently springy, grooves are not required on the shaft 15 of theneedle as the spring arms 62 will firmly hold the shaft in position.

A third fixing system 50″ is seen in FIG. 3C and includes a plasticscrew 65 which extends around the shaft 15 of the surgical instrument14, and an inner thread 66 located on the handle or knob 20 of theneedle 12. When it is desired to fix the surgical instrument 14 relativeto the needle 12, the screw 65 is screwed into the threaded handle orknob needle 20 of the needle 12. The plastic screw 65 and the innerthread 66 of the handle or knob 20 of the needle are sized to cause theplastic screw 65 to deform and tighten around the shaft 15 when thescrew 65 is screwed into the thread 66, thereby fixing the locations ofthe needle 12 and surgical instrument 14 relative to each other. When itis desired to release the surgical instrument 14, the screw 65 isunscrewed sufficiently to permit movement of the surgical instrumentrelative to the needle. As will be appreciated by those skilled in theart, the screw 65 may have a gripping member such as a head (not shown)to help the practitioner apply torque.

FIG. 3D shows a fourth fixing system 50′″ which includes a thumb screw70 and a handle portion 20 of the needle 12 which includes a thread (notshown), and which is flexible or plastic. In particular, the thumb screw70 when screwed onto the handle portion threads causes the handleportion to clamp down on the shaft 15 of the surgical instrument 14 andlock the surgical instrument relative to the needle.

A fifth fixing system 50′″ is seen in FIG. 3E where a cam element 72 isrotatingly coupled to the needle handle 20′ by a pin 73. When in a firstorientation, the cam element 72 permits a rear portion 15′ of the shaft15 of the surgical instrument 14 to move in an uninhibited manner. Whenin a second orientation as shown in FIG. 3E, the cam element 72 engagesthe rear portion 15′ of the shaft 15 and holds it fixed relative to theneedle handle 20′ and needle 12. It will be appreciated that in additionto the fixing system 50′″ which is different the fixing systems of FIGS.3A-3D, the needle handle 20′ and surgical instrument handle 24′ aremodified relative to the handles 20, 24 shown in FIGS. 1 and 2 and FIGS.3A-3D.

The assembly also preferably includes a second fixing element whichmoves relative to the needle and is located on the outside thereof andwhich is used to fix the relative location of the needle to the patient.More particularly, as seen in FIG. 4, the second fixing element is asoft plastic suction cup 80 which engages and is frictionally slidableover the outer surface of the needle 12, and which can be pressedagainst the abdominal wall of a patient to cause a suction connection.If desired, the outer surface of the needle 12 may be provided withmating elements such as bumps, serrations, or grooves (not shown), andthe suction cup 80 may be provided with a reciprocal mating element (notshown) for engaging the mating element of the outer surface of theneedle 12 to more strongly fix the location of the suction cup 80relative to the needle 12.

Turning to FIGS. 5A and 5B, a second embodiment of the second fixingassembly is seen to include a plastic suction cup 80′ having a topproximal hole 82 and a plurality of bayonet-type grooves 84 throughwhich the needle 12 can be maneuvered. The suction cup 80′ therebypermits the needle 12 to be held at different angles relative to thepatient.

In lieu of a suction cup, it is possible to fix the location of theneedle 12 and surgical instrument 14 relative to the patient by usingstandard equipment and modifying the surgical assembly of the inventionslightly. Thus, as seen in FIG. 6, a standard multiheaded clip 90 isprovided which is fixed by a clamp 92 to the side of an operating roomtable. The multiheaded clip 90 includes a malleable metal rod 94 and aplurality of clip elements 96. The surgical assembly 10 may then be heldin a desired position relative to the patient by providing the needle 12or surgical instrument 14 with a clip receiver or groove which may belocated on the outside surface of the needle handle or on the handle orknob of needle or surgical instrument. Details of a presently preferredmultiheaded clip can be found in co-owned U.S. Ser. No. 11/668,169 filedJan. 29, 2007 and entitled “Platform for Fixing Surgical InstrumentsDuring Surgery”.

As will be appreciated by those skilled in the art, the surgicalinstrument 14 of the invention may take various forms. Thus, FIGS. 7A-7Gshow representations of seven different end effectors for the surgicalinstrument of the invention (although others could be utilized). FIG. 7Ashows a detailed view of a grasper such as seen in FIGS. 1 and 2. Thegrasper end effectors 101 include two arms 102 which extend from shaft15, each of which is approximately 19 mm (0.75 inch) long. The arms areslightly rounded on their outer peripheries in the same profile as theshaft 15, with each rounded surface forming an arc of between forty-fiveand ninety degrees. The first portions 104 (e.g., about 4 mm) of thearms are relatively straight in their at rest open position. The middleportions 106 of the arms 102 then angle away from each other (each atbetween 6.degree. and 18.degree. from the horizontal) until they extendapproximately 7 mm apart from each other. In order to provide a goodspring load, the middle portions of the arms may be reinforced with orformed from spring steel. The tips 108 (e.g., approximately 3 mm) of thearms are then bent back to parallel the first portions 104. Their outersurfaces may also be flattened.

If desired, the grasper of FIG. 7A can be formed from a solid rod or atube of steel, by cutting the end of the tube in half to form arms(e.g., via use of a laser or an EDM machine), further removing materialfrom the underside of each arm at the first portions 104, and thenbending the arms at the intersections of the first portions 104 andmiddle portions 106, and at the intersections of the middle portions 106and tips 108.

FIG. 7B is a representation of lung clamp end effectors 111. The lungclamp end effectors extend from the shaft 15 with arms 112 whichterminate in loops 114 which define openings 115. While not shown indetail in FIG. 7B, the arms 112 are similar to the arms of the grasperof FIG. 7A in that they are slightly rounded on their outer peripheriesin the same profile as the shaft 15, include first portions 116 whichare relatively straight in their at rest open position and middleportions 118 which angle away from each other until they extendapproximately 6 mm apart from each other. The loops 114 are then bentback to parallel the first portions 116. In order to provide a goodspring load, the middle portions of the arms may be reinforced with orformed from spring steel.

FIG. 7C is a representation of hybrid end effectors 121 including onegrasper 122 and one lung clamp 123. The grasper 122 is substantially asdescribed above with reference to FIG. 7A, and the lung clamp 123 issubstantially as described above with reference to FIG. 7B.

FIG. 7D is a representation of non-crushing clamping end effectors 131including one grasper 132 and a rubber covered arm 133.

FIG. 7E is a representation of retractor end effectors 141. Theretractor end effectors 141 are formed from wire mesh elements 143 whichat rest are substantially flat, but which are bent into an arcuate shapewhen retracted into the needle.

FIG. 7F is a representation of a grasper similar to that of FIG. 7A. Theprimary differences between the grasper end effectors 151 of FIG. 7F andthe grasper end effectors 101 of FIG. 7A are that the arms 152 are eachapproximately 25 mm-35 mm (1-1.38 inch) long, the middle portions 156angle away from each other at about 50.degree. or 25.degree. from thehorizontal. The tip portions 158 shown in FIG. 7F are approximately 12mm long and bend back slightly beyond being parallel to the firstportions 154 so that they are angled slightly toward each other.Alternatively, the tip portions need not bend back beyond the parallelor even at all. If the tip portions are not bent back, the tip portionsmay be designed to open 15 mm-20 mm relative to each other.

FIG. 7G is a representation of a crushing grasper 161 shown in a closedposition within a needle 12. The crushing grasper 161 is similar to thegrasper 101 of FIG. 7A except that it is slightly longer (approximately22 mm long), and the tip portions 168 have teeth 169 a and have arounded front 169 b such that they present a blunt almost hemisphericalsurface. When the end effectors 161 of FIG. 7G are moved forwardrelative to the needle 12, they preferably remain in a closed positionuntil approximately half the length of the arms 162 extend beyond theneedle. Thus, as will be discussed below, the end effectors of thesurgical instrument 14 may act as an obturator relative to the needle toguard the needle from causing accidental needle tip trauma.

The surgical assemblies of the invention may be used during laparoscopicsurgery instead of using extra trocars and laparoscopic instruments. Inparticular, with the surgical instrument 14 (e.g., grasper end effectors111) partially inserted in the needle 12 (i.e., with the end effectorswithdrawn at least partially inside the needle) and optionally lockedrelative to each other by the first fixing element (e.g., fixing system50), the needle 12 is used to puncture the skin and advance into thebody (e.g., the abdomen). At a desired location (typically underguidance of an already inserted scope), the movement of the needle isstopped. The surgical instrument 14 is then unlocked (if previouslylocked) and advanced until the end effectors 111 extend past the needle12 and open toward their neutral stress position. The needle andsurgical instrument may then further advanced until the end effectorsextend over a structure in the body. Then, with the surgical instrumentstationary, the needle is advanced relative to the surgical instrumentto force the end effectors 111 closed, thereby securely grasping thestructure. The first fixing element or system (e.g., system 50) may thenbe used to fix the needle relative to the surgical instrument to preventrelease of the grasped structure. If desired, the needle with thesurgical instrument fixed relative thereto and grasping the structuremay be manipulated relative to the body wall (e.g., to lift, push, orotherwise move the structure). When the needle (or the graspedstructure) is in a desired location in the body, the second fixingelement (e.g., 80) is slid along the needle and into engagement with theskin of the patient, thereby fixing the grasping end effectors at adesired location in the body. At any time, the grasped structure can bereleased by causing the first fixing element to release the surgicalinstrument and then moving the needle backward relative to the surgicalinstrument, thereby permitting the end effectors to reopen. The surgicalassembly can be pulled out of the body (preferably with the surgicalinstrument first moved backward at least partially relative to theneedle to retract and close the end effectors) leaving just a smallpuncture mark which will often heal without a scar.

It is noted that because of the small diameter of the surgical assembly,withdrawal of the needle assembly from the abdomen will not causedesufflation, and should not require stitching to close the wound. It isalso noted that because of the small diameter of the surgical assemblythe elimination of a trocar port, the surgical assembly can be easilymoved in any direction (i.e., it can be easily angled) during surgery.

The surgical assembly of the invention thereby accomplishes the objectsof the invention with a minimum number of parts and may be used toreplace expensive trocar assemblies and laparoscopic instruments.

According to another aspect of the invention, as previously mentioned,the tips of the end effectors of the surgical instrument may be used tofunction as an obturator. Thus, as seen in FIGS. 8A-8D, a surgicalassembly combining aspects seen in FIGS. 3E and 7G is shown, except thata spring 193 is provided and coupled to the handles 20′, 24′ of theneedle and surgical instrument respectively. Spring 193, in an at restposition, causes the rounded end effectors 161 to assume a positionwhere the end effectors extend out of the needle 12 but remain in aclosed position as seen in FIG. 8A. In this partially extended position,the end effectors 161 act as an obturator or protection from accidentalneedle tip trauma. When the surgical assembly is used to puncture skinas seen in FIG. 8B, pressure is placed on the end effectors, therebycausing the end effectors 161 to be pushed back into and therebyexposing the needle, and causing the surgical instrument to movebackward relative to the needle, thereby placing spring 193 undertension. When the skin is punctured and the needle extends into a cavityand pressure on the end effectors is released, the spring 193 pushes thesurgical instrument forward to reassume the position of FIG. 8A. When itis desired to extend the end effectors 161 to grasp a structure, thesurgical instrument may be pushed forward relative to the needle as seenin FIG. 8C, thereby placing the spring 193 under compression, andopening the end effectors 161. The end effectors may then be closed overthe object by pulling end effectors backward relative to the needlewhereby the needle acts on the end effectors to at least partially closethem, with the spring 193 assuming a partially compressed position. Thegrasping position (and any other position) may be locked at any timeusing the fixing element (e.g., cam 72). If it is desired to pull theend effectors totally into the needle as seen in FIG. 8D, that may beaccomplished by pulling the surgical instrument backward relative to theneedle, again placing the spring 193 in tension. The surgical instrumentcan be locked in that position using the fixing element.

Use of a plurality of surgical assemblies 10 a-10 d is seen in FIGS.9A-9D with respect to a hernia repair operation. In particular, anabdominal wall 200 is seen with a hernia (opening) 290. The hernia 290is to be repaired with mesh 290 which has been inserted into the abdomenunder guidance of a laparoscope (not shown). As seen in FIG. 9A, foursurgical assemblies 10 a-10 d according to the invention have been usedto pierce the abdominal wall. The four assemblies 10 a-10 d are thenused to grasp corner areas of the mesh 295 by moving the grasper endeffectors out of their respective needles and over and around the meshcorners, and by moving the needles forward relative to the grasperinstruments to force the end effectors closed over the mesh. The needlesand surgical instruments are then preferably locked relative to eachother (using first fixing mechanisms or systems such as discussed abovewith reference to FIGS. 3A-3E), and the assemblies 10 a-10 d are pulledupward to cause the mesh 295 to lie directly below the hernia 290 asseen in FIG. 9B. The assemblies are then preferably locked in placerelative to the abdominal wall using mechanisms such as discussed abovewith reference to FIGS. 4, 5A, 5B, and 6. Then, using a laparoscopicstapler (not shown) typically introduced through a standard trocar port,the mesh is stapled in place. The mesh may then be released by theassemblies 10 a-10 d by unlocking the surgical instruments, unlockingthe second fixing mechanisms, and moving the respective needles backwardin order to open the end effectors. After the mesh is released, the endeffectors of the surgical instruments are withdrawn at least partiallyinto the needles (and optionally locked in place), and withdrawn fromthe abdomen, leaving the mesh 295 stapled in place as seen in FIGS. 9Cand 9D.

It will be appreciated by those skilled in the art that the minimallyinvasive surgical assemblies of the invention can be used for variousother surgical procedures, including but not limited to tuboplasty,gastric bypass, bowel connection, kidney surgery, appendectomy,menisectomy, discectomy, etc. The minimally invasive surgical assembliesof the invention also have particularly advantageous use in neonatal andpediatric surgeries, and the assemblies and methods can be used onanimals or cadavers.

Another embodiment of the surgical assembly of the invention is shown inFIGS. 10-20B. As seen in FIGS. 20A and 20B, the assembly 510 includes aneedle 512 and a medical instrument 514. The needle has a sharpeneddistal tip 518 and a handle 520. The medical instrument has endeffectors 522 and a handle 524. Also shown in FIGS. 20A and 20B is alever 554 of a safety lock mechanism 550 which also serves as a firstfixing mechanism. Seen in FIG. 20A is a second fixing assembly 800discussed hereinafter with reference to FIGS. 21A-21G. Details of theneedle 512, the medical instrument 514, and the safety lock mechanism550 and the functioning of the safety lock mechanism are seen in FIGS.10-20B.

The handle 520 of the medical instrument is seen in FIG. 10. Handle 524includes a loop 601 which is sized to receive the thumb of apractitioner and a post 603 which extends in a direction parallel orcoaxial with the shaft of the instrument 514. The post 603 may beprovided with a seat 605 which can be used to receive a pin 607 (FIG.16D) which will fix the handle 520 relative to the remainder of themedical instrument 514 as discussed below.

The post 603 of the handle 524 is received in a plunger 610 shown inFIGS. 11A-11C. More particularly, plunger 610 is a cylindrical memberhaving a head 611 and defining a top tubular opening 612, a pin hole613, a bottom tubular opening 614, a shaft surface 615 defining a firstgroove 616 which stops at a stop surface 617, a second groove 618, aflattened distal portion 620 which helps define a stop surface 621 forgroove 618, and a bevel 622. The top opening 612 receives the post 603of the handle 520, and a pin 607 (FIG. 16D) is inserted in pinhole 613so as to engage the seat 605 of the post 603. The pinhole 613 iseccentric relative to the post 603 so that it engages seat 605 and fixesthe handle 524 axially relative to the plunger 610, but permits thehandle 524 to rotate relative to the plunger. The bottom tubular opening614 is provided for receiving the shaft 515 of the medical instrument(the top portion of which is shown only in FIG. 11B). If desired, theplunger 610 can be formed as a cylinder with a single passagewaydefining openings 612 and 614.

The grooves 616 and 618 defined in the shaft surface 615 of the plunger610 are used to perform several functions. As will be described in moredetail hereinafter, groove 616 is used to fix the orientation of the endeffectors 522 of medical instrument 514 relative to the bevel of the tipof the needle 512. The stop surface 617 at the end of groove 618 alsoprevents the medical instrument 514 from being completely removed fromthe needle 512. Groove 618, together with flattened portion 620, stopsurface 621, and bevel 622 work together with lever 554 (FIGS. 14 and20) to provide a safety lock and a first fixing means 550 for theassembly 500.

Turning now to FIGS. 12A, 12B, 13A, and 13B, the handle 520 for theneedle is seen. The handle 520 is preferably formed from two similarmating parts 520A, 520B which when mated together form generally aspool-shaped handle. As seen in FIGS. 12A and 12B, handle portion 520Aincludes four internal mating posts 622A, a rotation post 624A, a springcatch or notch 625, a location tongue 626, plunger locating ribs 628A, aneedle hub locating rib 629A and a needle shaft locating rib 630A.Portion 520A also has an outer surface with lower and upper ribbedportions 632A, 634A, a smooth hourglass shaped waist 636A therebetween,with the lower ribbed portion 632A defining an opening 638A for theneedle shaft, and the upper ribbed portion 634A defining an opening 639Afor the plunger. The upper ribbed portion 634A also defines an opening640A for the lever 554 as will be discussed hereinafter with a stopsurface 641A. As seen in FIGS. 13A and 13B, handle portion 520Bgenerally corresponds to handle portion 520A, and with four internalmating post receivers 622B, a rotation post receiver 624B, plungerlocating ribs 628B, needle hub locating rib 629B with locating notch629B1, and a needle shaft location rib 630B. Portion 520B also has anouter surface with lower and upper ribbed portions 632B, 634B, a smoothhourglass shaped waist 636B therebetween, with the lower ribbed portion632B defining an opening 638B for the needle shaft, and the upper ribbedportion 634B defining an opening 639B for the plunger. The upper ribbedportion 634B also defines an opening 640B for the lever 554 with a stopsurface 641B as will be discussed hereinafter.

Lever 554 is seen in FIGS. 14, 18A and 18B, and includes a concaveribbed friction surface 644, a body 646 defining a hole 647 and a springseat 648 (seen in FIG. 18A) for housing a spring 649, and a nose 650.The hole 647 is sized to receive the rotation post 624A such that thelever 554 can rotate about the post. The nose 650 is generallytriangular in shape with an angled top surface 650A and a straightbottom surface 650B and has a first width which permits the nose 650 toride in groove 618 of the plunger. The body 646 has a second largerwidth which is sized to fit within an opening into the handle formed byopenings 640A, 640B. As will be discussed hereinafter, the roundedportion 652 of the body adjacent the top of the nose is used as thefirst fixing element for the assembly. The friction surface 644 has apreferably a third even larger width and is located outside the matingparts 520A, 520B of the handle.

Turning now to FIGS. 15A and 15B, the proximal and distal portions ofthe needle 512 are seen. More particularly, as seen in FIG. 15B, thedistal tip 518 of the hollow needle is beveled and sharp. As seen inFIG. 15A, the proximal end of the hollow needle 512 is provided with ahub 655 with a boss 656. As indicated by FIG. 20B, the hub 655 is sizedto be captured in a hole formed by the needle hub receiving ribs 629Aand 629B, with the boss 656 received in the cutout 629B1 so as to orientthe needle bevel in a desired orientation relative to the handle 520. Ifdesired, the proximal portion of the needle shaft may be textured toprovide an extra gripping surface for the practitioner.

Prior to discussing the functioning of the plunger 610 and lever 554, acouple of additional aspects of the invention are worth noting. First,the spring seat 648 (FIG. 18) and spring catch or notch 625 (FIG. 12A)are arranged to cause the spring 649 to bias the lever 554 in aclockwise direction into a position where the nose 650 is substantiallyperpendicular to the perpendicular axis of the plunger 610 and needle512. Rotation of the lever 554 clockwise from that position is stoppedby the surface 641A, 641B of the upper ribbed portions of the spool.Rotation of the lever 554 counterclockwise, against the spring can beaccomplished easily by applying a small amount of counterclockwise forceto the lever 554. Second, while grooves 616 and 618 are shown in FIGS.11A-11C to be one hundred eighty degrees apart, they are more preferablyninety degrees apart, and their actual locations must be considered inconjunction with the location of pin 624A (FIG. 12A) which sets theposition of the lever 554 and the tongue 626 (FIG. 12A) which rides ingroove 616. Third, the orientation of the needle 512 through the use ofthe needle hub 655 and nub 656 (FIG. 15A) and the needle hub receivingribs 629A, 629B and locating notch 629B1 is preferably selected relativeto the orientation of the end effectors of the surgical instrument 514(which are fixed relative to the plunger 610) so that the end effectorspresent themselves in a shielding manner relative to the bevel tip 518of the needle 512. In particular, according to one aspect of theinvention, it is desirable for the end effectors 518 to present as shownin FIG. 17 with the full, typically rounded outer surface 518 of one endeffector resting along the very tip 599 of the bevel edge of the needleas opposed to the being rotated relative thereto. In this manner thesurface 518 of the end effector effectively continues and/or rounds thebeveled surface of the needle, i.e., it acts as an internal shield sothat the exposure of the sharpness of the needle is significantlyreduced. Fourth, if desired, the distal portion of the plunger 610(including the flattened portion 620) may be colored with a red or otherpigment (not shown) so that it is highly visible as discussedhereinafter.

The functioning of the plunger 610 and the lever 554 in order to providea safety locking function and a first fixing function is understood bestwith reference to FIGS. 16-19. More particularly, FIG. 16A shows thepositions of the plunger 610 and the lever 554 when the assembly in an“armed” position with the medical instrument 514 fully retractedrelative to the needle 512 so that the needle tip 518 is not guarded bythe end effectors. In the position of FIG. 16A, the tongue 626 (FIG.12A) of the spool engages the stop surface 617 (FIGS. 11B and 11C) ofthe plunger 610. Also, in the position of FIG. 16A, the nose 650 of thelever 554 either doesn't engage the plunger 610 at all, or engages thebeveled end 622 of the plunger. In this armed position, the assembly 510(and in particular the needle 512) can be used to puncture the skin of apatient so that the distal end of the assembly can pass into a bodycavity (e.g., the diaphragm). Also, in this position, the distal portionof the plunger 610 extends out of the needle handle 520. If this portionof the plunger is made highly visible with coloration, the practitioneris given a viewable warning that the assembly is armed (i.e., the needleis unshielded).

After passing through the skin layers, it is desirable to move thesurgical instrument 514 forward so that the end effectors will protect(guard) the bevel of the needle. As seen in FIG. 16B, as the plunger 610of the surgical instrument 514 is moved forward relative to the needle,the bevel 622 of the plunger works against the angled top surface 650Aor the nose 650 of the lever 554 such that the lever 554 rotatescounterclockwise against the spring 649 (FIG. 18A). Further movement ofthe plunger 610 (FIG. 16C) causes the nose 650 to ride in the flatteneddistal portion 620 of plunger 610 as the end effectors start to emergefrom the back of the bevel. When the plunger 610 is moved a littlefurther as seen in FIG. 16D, the nose 650 reaches the groove 618 and thetop angled surface 650A of the nose is no longer contacted by theplunger 610. As a result, the spring 649 rotates the lever clockwiseuntil the bottom surface 650B of the nose 650 is generally perpendicularto the axis of the plunger 610 and the nose 650 rides in groove 618. Asseen in FIG. 16D, if at this point an attempt is made to retract thesurgical instrument from the needle, the flat surface 650B of the nosehits the stop surface 621 of the groove 618 and prevents such movement;i.e., the assembly is in a safety position. When in this safetyposition, the end effectors extend beyond the very distal tip of thebevel of the needle 512 and guard the tip of the needle as shown in FIG.17. The only manner of withdrawing the end effectors in order to rearmthe needle is to override the stop by manually forcing the leverclockwise, thereby pushing the plunger 610 slightly forward andpermitting the nose to ride again in flattened area 620.

Once the assembly has reached the safety position, the operator is freeto move the plunger up and down within the operating range of theassembly to cause an opening and closing of the end effectors (asdiscussed with reference to the previous embodiments of the invention).The operating range is defined by the stop position of FIG. 16D and aposition where the top surface of the handle 520 of the needle 512 abutsthe head 611 of the plunger 610 of the surgical instrument 514. FIG. 16Eshows the assembly in an operating range with the nose 650 of the leverlocated in the groove 618.

At any point in the operating range of the assembly, the relativelocation of the instrument 514 and the needle 512 can be fixed orlocked. This is accomplished by rotating the lever 554 clockwise againstthe spring force until the rounded portion 652 of the body 646 of thelever adjacent the top of the nose 650 (which is wider than the nose 650and the groove 618) frictionally engages the shaft surface 615 of theplunger 614 about the groove 618 as seen in FIGS. 19A and 19B. Thefrictional forces of this engagement are arranged to be greater than thespring force of spring 649 so that spring 649 does not automaticallydisengage rounded portion 652 from the surface 615, and preferably largeenough to prevent inadvertent movement of the instrument relative to theneedle. With this arrangement, large tensile loads applied to the endeffectors relative to the needle may result in slippage of the lockingmechanism, and large compressive loads can cause unlocking. In normalutilization, if it is desired to unlock the instrument from the needle,the lever 554 may be rotated counterclockwise so that the assembly canbe used in its operating range. As with the other embodiments of theinvention, removal of assembly 510 from a body can be accomplished withthe end effectors opened or closed.

Turning now to FIGS. 21A-21G, a third embodiment of a second fixingmeans is seen for fixing the surgical assembly relative to the body ofthe patient. The second fixing means 800 includes three elements: a base810, a compressible ball 820 and an actuating body 830. The base 810 ofthe second fixing means 800 seen best in FIGS. 21A, 21D and 21G isessentially a washer, having a flat bottom surface 832 to which anadhesive layer 834 (and a peelable protective paper layer—not shown) maybe applied, a frustroconical central opening 836 (see FIG. 21D), and atop surface 838 which defines finger grips 841 and a central ring 844.Ring 844 defines a slightly tapered inner surface 845 (FIG. 21D) forreceiving the ball and three separate outer ramps 846 which are recessedinto the ring and start at the top surface 847 of the ring and descendas they extend clockwise about the ring until they reach the top washersurface 838. As seen best in FIG. 21G, the ramps 846 are slightlyrecessed relative the openings on the top surface 847 of the ring toform small ledges 848 for purposes explained hereinafter.

The ball 820 is a preferably hollow plastic ball and is provided withopposite circular openings 851, 852 sized to closely receive the needleshaft of the surgical assembly 510, and a plurality of slits 853 whichextend about 120.degree. from the opening 852 in the direction of theaxis defined by openings 851, 852. With the slits 853, the ball iscompressible such that if a circumferential force is applied to theball, the lobes 854 formed between the slits 853 will move toward eachother. As seen best in FIGS. 21A-21D, the ball 820 is oriented in thering 844 so that the slits 853 extend downward.

The actuating body 830 is seen best in FIGS. 21A and 21E and iseffectively comprises a cap 860 with extending arms 862. The cap 860 hasa top wall 864 with a central opening 865 through which the top portionof the ball 820 can extend. The cap 860 also has a side wall 866 withcut-outs which define engagement fingers 868. The engagement fingers 868have bosses 869 which are sized to ride in the ramps 846 of the ring844. As seen best in FIG. 21E, the inward facing bosses are ramped orbeveled.

In assembly, the ball 820 is placed between the actuating body 830 andthe base 810, and the bosses 869 are forced over the ledges 848 and intoengagement with the ramps 846. In this position the bottom of the sidewall 866 of the cap 860 of the actuating body is spaced relative to thetop surface 838 of the washer (see FIG. 21D), and the ball is free torotate as guided by the ring 844 and central opening 865. Thus, when ashaft of the surgical assembly is inserted through the circular openings851, 852 of the ball, the shaft will have considerable freedom ofmovement, limited only by the size of the central opening 865 of the cap860 and the frustroconical central opening 836 of the base. Preferably,the second fixing means 800 provides the assembly with a freedom ofmovement of at least forty-five degrees relative to the vertical in alldirections. However, when the actuating body 830 is rotated clockwiserelative to the base 810 (typically by squeezing arms 862 and 841together with a thumb and forefinger), the bosses 869 ride down theramps 846 and pull the body 830 closer to the base 810. Because the ball820 cannot move downward in the ring, the central opening 865 provides acircumferential force to the ball (i.e., it compresses the ball),thereby forcing the lobes 854 inward, and applying friction to the shaftof the surgical assembly. As a result, not only is the shaft locked inplace in the ball 820, but the ball is fixed in its rotationalorientation in the fixing means 800. The ball 820 and shaft may bereleased by rotating the body 830 counterclockwise relative to the base(typically by squeezing the other arms 862, 841 together). The body 830,however, cannot lift of the base 810 because the ledges 848 act asstops.

There have been described and illustrated herein several embodiments ofa minimally invasive surgical assembly and methods its use. Whileparticular embodiments of the invention have been described, it is notintended that the invention be limited thereto, as it is intended thatthe invention be as broad in scope as the art will allow and that thespecification be read likewise. Thus, while particular materials formaking the needle and surgical instrument have been disclosed, it willbe appreciated that other materials may be used as well. In addition,while particular fixing elements and systems have been disclosed forfixing the surgical instrument relative to the needle, it will beunderstood that other mechanisms can be used. For example, and not byway of limitation, a latch-catch system can be used. Also, whileparticular fixing elements and systems for fixing the location of thesurgical assembly relative to the patient have been described, it willbe recognized that other mechanisms can be used for that as well.Furthermore, while particular end effectors such as graspers, lungclamps, etc., have been described for the surgical instrument, it willbe understood that instruments with different end effectors such as (butnot limited to) dissectors, staplers, scissors, suction/irrigators,clamps, biopsy forceps, etc., can be similarly used. Also, the arms ofthe end effectors need not be of equal length. Further, while thesurgical instrument and needle have been shown as being straight,because of their small diameter they may be bent together by the user,or one or both may be formed with a bend (arc). Moreover, whileparticular configurations have been disclosed in reference to thehandles of the surgical instrument and the needle have been disclosed,it will be appreciated that other configurations could be used as well.In addition, while the needle was described as being a particular sizeand having a sharp end with a certain angle, it will be appreciated thatother size needles can be used and the sharp can be at different angles.It will therefore be appreciated by those skilled in the art that yetother modifications could be made to the provided invention withoutdeviating from its spirit and scope as claimed.

What is claimed is:
 1. A surgical assembly, comprising: a hollow needlehaving an outer diameter of 3 mm or smaller and a sharp distal end, afirst handle coupled to a proximal portion of said hollow needle, asurgical instrument having a shaft which extends through said hollowneedle and including end effectors at an end of said shaft which arebiased open, a plunger coupled to a proximal portion of said shaft andcoupled to said first handle, said plunger configured for longitudinalmovement relative to said first handle, and a safety mechanismconfigured to establish a predetermined working range for said surgicalinstrument, wherein said end effectors have opposed distal tips that aresubstantially separated from one another in a first extended positionand that are disposed in proximate contact to one another in a secondextended position, wherein the end effectors are moveable relative tothe hollow needle to a retracted position wherein the opposed distaltips of the end effectors are positioned proximal relative to the sharpdistal end of the hollow needle to thereby expose the sharp distal end,and wherein said predetermined working range includes the first extendedposition and the second extending position, and said safety mechanismincludes a stop body biased to limit proximal movement of said surgicalinstrument relative to said hollow needle beyond said predeterminedworking range thereby preventing said surgical instrument from beingmoved from said predetermined working range to said retracted position,said stop body being biased towards a central axis of said plunger tointerfere with said plunger to limit proximal movement of said surgicalinstrument relative to said hollow needle beyond said predeterminedworking range.
 2. The surgical assembly according to claim 1, whereinsaid hollow needle has an inner surface and said shaft has an outersurface, and said outer surface and said inner surface are sized so thatat least a portion of said shaft interferingly slides against said innersurface of said hollow needle, thereby forming a seal which is effectiveagainst desufflation.
 3. The surgical assembly according to claim 1,further comprising a fixing element coupled to and movable relative tosaid hollow needle for fixing a relative location of said hollow needleto a patient.
 4. The surgical assembly according to claim 3, whereinsaid fixing element comprises a suction cup extending around said hollowneedle.
 5. The surgical assembly according to claim 1, wherein saidhollow needle is between 13 cm and 18 cm long.
 6. The surgical assemblyaccording to claim 1, wherein said end effectors open to a distancebetween them of more than twice a diameter of said hollow needle.
 7. Thesurgical assembly according to claim 1, wherein said end effectors havefirst portions coupled to said shaft and extending substantiallyparallel to a longitudinal axis of said shaft, second portions whichangle away from said longitudinal axis at between 6° and 18° in thefirst extended position, and third portions which angle back from saidsecond portions toward said longitudinal axis.
 8. The surgical assemblyaccording to claim 7, wherein said third portions are substantiallyparallel to said longitudinal axis.
 9. The surgical assembly accordingto claim 1, wherein the hollow needle has a central axis and the sharpdistal end of said hollow needle has an end wall angled at substantially35° relative to the central axis.
 10. The surgical assembly according toclaim 1, wherein the end effectors are moveable relative to the hollowneedle to a partially-extended position wherein the opposed distal tipsof the end effectors are positioned outside but close to the sharpdistal end of the outer hollow needle such that the end effectors act asan obturator for protecting against accidental trauma caused by thesharp distal end of the outer hollow needle.
 11. The surgical assemblyaccording to claim 1, wherein a longitudinal groove is formed on saidplunger, said longitudinal groove having a stop surface at a distalportion of said plunger, and wherein said longitudinal groove receives amember of said stop body and said stop surface engages said member ofsaid stop body to limit proximal movement of said surgical instrumentrelative to said hollow needle beyond said predetermined working range.12. The surgical assembly according to claim 11, further comprising asecond handle coupled to a proximal portion of said plunger via arotational linkage.
 13. The surgical assembly according to claim 12,wherein said plunger has a tubular opening formed in a proximal end ofsaid plunger, and said tubular opening receives a post of said secondhandle.
 14. The surgical assembly according to claim 13, wherein thepost has an annular groove formed therein, and said groove receives apin through a pin hole formed in said plunger to couple said secondhandle to said plunger while permitting relative rotation therebetween.15. The surgical assembly according to claim 1, wherein a member of saidstop body includes a nose, and said stop body is rotatably coupled tosaid first handle, wherein said plunger includes a groove, and whereinthe nose of said stop body and the groove of said plunger interact witheach other to limit proximal movement of said surgical instrumentrelative to said hollow needle to prevent said surgical instrument frombeing moved from said predetermined working range back to said retractedposition.
 16. The surgical assembly according to claim 15, wherein thegroove of said plunger has a flattened distal portion forming a stopsurface, wherein the nose has a bottom surface, and said stop body isbiased such that the bottom surface extends generally perpendicular toan axis of said plunger, and wherein the stop surface interacts with thebottom surface of said stop body to limit proximal movement of saidsurgical instrument relative to said hollow needle.
 17. The surgicalassembly according to claim 1, wherein said first handle has an outersurface including a lower ribbed portion and an upper ribbed portion,and wherein said first handle includes a hourglass shaped waist betweenthe lower ribbed portion and the upper ribbed portion.
 18. The surgicalassembly according to claim 17, wherein the upper ribbed portionincludes an opening for housing said safety mechanism.